BS EN IEC 60601-2-31:2020
Medical electrical equipment Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
| Standard number: | BS EN IEC 60601-2-31:2020 |
| Pages: | 60 |
| Released: | 2023-01-27 |
| ISBN: | 978 0 539 25756 4 |
| Status: | Corrigendum |
BS EN IEC 60601-2-31:2020 Medical Electrical Equipment
Introducing the BS EN IEC 60601-2-31:2020 Medical Electrical Equipment - a comprehensive guide that outlines the particular requirements for the basic safety and essential performance of external cardiac pacemakers with an internal power source. This document is a must-have for all professionals in the medical field, especially those dealing with cardiac health and technology.
Product Details
The BS EN IEC 60601-2-31:2020 is a standard document that was released on the 27th of January, 2023. It spans across 60 pages of detailed information, ensuring that you have all the necessary knowledge at your fingertips. The ISBN for this document is 978 0 539 25756 4.
Essential for Cardiac Health Professionals
External cardiac pacemakers with an internal power source are crucial devices in the medical field. They help regulate the heartbeat of patients with certain heart conditions. This document provides the particular requirements for the basic safety and essential performance of these devices, making it an invaluable resource for all cardiac health professionals.
Comprehensive and Detailed
The BS EN IEC 60601-2-31:2020 is not just a standard document. It is a comprehensive guide that provides detailed information on the safety and performance requirements of external cardiac pacemakers. It covers everything from the design and manufacturing process to the testing and maintenance of these devices. With this document, you can ensure that your devices meet the highest standards of safety and performance.
Up-to-Date Information
The medical field is constantly evolving, and so are the standards that govern it. The BS EN IEC 60601-2-31:2020 is the most recent version of this standard, ensuring that you have the most up-to-date information. It also includes a corrigendum, which corrects any errors or omissions in the previous versions of the standard.
Easy to Understand
Despite its technical nature, the BS EN IEC 60601-2-31:2020 is written in a way that is easy to understand. It uses clear language and includes diagrams and illustrations to help explain complex concepts. This makes it a useful resource for both seasoned professionals and those new to the field.
Conclusion
The BS EN IEC 60601-2-31:2020 Medical Electrical Equipment is more than just a standard document. It is a comprehensive guide that provides detailed, up-to-date information on the safety and performance requirements of external cardiac pacemakers with an internal power source. Whether you are a seasoned professional or new to the field, this document is an invaluable resource that will help you ensure the highest standards of safety and performance for your devices.
Don't miss out on this essential resource. Get your copy of the BS EN IEC 60601-2-31:2020 today!
BS EN IEC 60601-2-31:2020
This standard BS EN IEC 60601-2-31:2020 Medical electrical equipment is classified in these ICS categories:
- 11.040.01 Medical equipment in general
- 11.040.40 Implants for surgery, prosthetics and orthotics
IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) The requirement for testing for energy reduction has been removed;
b) The test for exposure to external defibrillation has been completely revised;
c) The exclusion for testing ESD immunity only with respect to air discharges has been removed;
d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117;
e) Additional rationale for all changes.